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ACIP is re-voting on the VFC resolution tied to the MMRV vaccine. Jason Goldman, president AFP, is arguing that by questioning that vote, it revealed a truth about the merits of the new MMRV recs. Retsef Levi accuses him of "trying to provoke a discussion that is has no merit."
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On the vote to change the VFC resolution so it reflects the recommendations to not recommend the combined MMRV shot for kids under four: Yes: 9 Abstain: 3
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On the vote that all pregnant women should be tested for hepatitis B: Yes: unanimous Carol Hayes from the American College of Nurse Midwives flags that this should be specified to test for the hep B antigen, not antibodies.
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Robert Malone motions to table the vote on the hepatitis B vaccine.
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The vote to table the vote that would push the hep B birth dose has been tabled. Yes: 11 No: 1
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there has never been a live event in the history of the world more impossible to pre-write than this meeting
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45 minutes into this meeting and liason members and ACIP members are sparring over processes and how work groups will be operating moving forward
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We'e onto Covid. CDC is presenting on epidemiology. WG chair Retsef Levi said in his intro: “We're going to very much stay away from the narratives or the statements about safety and effectiveness. We don't believe that these are appropriate, or scientific language..."
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Robert Malone appears to be taking issue with the credibility of Covid-19 tests that are used in COVID-NET. CDC officials say that they're using FDA-approved Covid tests.
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Rapid fire presentations. Three from CDC's Arjun Srinivasan, the last of which was on vaccine effectiveness. There was decent durability against the worst outcomes for some of the adults most at risk. Onto safety presentation.
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Our coverage of ACIP tabling a vote on the hepatitis B vaccine. It was whirlwind start to the morning, after the panel seemed poised to recommend that newborns get the shot at one month if a mother tests negative for the virus. But alas:
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CDC's John Su is presenting on safety, focusing on ischemic stroke signals among the mRNA vaccines and how they've been investigated. For example, a signal that arose from Pfizer's shot in older adults in '22-23 improved over time as more data were accrued.
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Wafik El-Deiry from @BrownUniversity and Dr. Charlotte Kuperwasser from @tufts are now presenting on "Safety Uncertainties of mRNA COVID Vaccines."
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A lot of interesting data and questions presented here that may have been good for the Covid vaccine manufacturers to address. But as a reminder:
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Those two researchers are part of the Covid-19 WG. Bruce Carleton, a Canadian researcher also part of the WG, is presenting on the genomics of vaccine-induced myocarditis. Sounds like he was included in the US gov's research pullback. Says he had a grant pulled back in March
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By my count we're on our 7th presentation in a row without ACIP or non-voting liason members being able to ask questions. @RWMaloneMD briefly did, and was able to clear up a question about Covid testing. At least it seemed to get cleared up.
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@RWMaloneMD Sanofi rep, which is leading US sales of Novavax's shot, props up the fact it is protein-based, not mRNA based. Moderna rep defends safety and critiques the earlier presentation from Brown and Tufts researchers. Pfizer says its vaccine saved ~5,000-7,000 lives in the last year.
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@RWMaloneMD The Covid-19 voting language has not be uploaded yet, about three hours from the scheduled voting time.
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@RWMaloneMD Meissner questions some of the data that CDC presents, namely the value of cumulative Covid-19 case rates.
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@RWMaloneMD Malone questions Moderna and Pfizer's biodistribution studies and alleges they did not use a sensitive enough assay. He also questions the testing of DNA fragments from vaccine lots. Moderna and Pfizer are saying they worked in concert with regulators
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As first reported by @endpts, the Covid-19 working group held a call with Pfizer last week, though details weren't disclosed. I'm curious if biodistribution or lot purity came up in that call. Sources told Endpoints that the vax makers weren't asked by WG to produce new data.
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@endpts FDA's Dr. Tracy Beth Hoeg said that the information provided to the FDA about the vaccines' pharmacokinetics "was within the regulatory limits." She says that FDA is discussing independent post-production evaluation of the products.
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@endpts Robert Malone asks the CDC if the Covid-19 has identified any correlate of protection for the virus. Before they answer, he says there isn't one and demands that agency staff "stop saying otherwise." Meissner tries to jump in, Malone barely let's him finish. Malone is pissed off.
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In broad strokes, the dialogue and discourse has been respectful at this ACIP meeting. There have been some chippy moments for sure. This was the first time that the CDC staff has been aggressively lambasted; like Malone was telling them they were grounded.
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Kulldorff, referencing Pfizer's placebo-controlled study in pregnant women, raises concerns about rate of birth defects. Using absolute figures he says there was a four-fold increase. 8 cases in vaxxed vs 2 in placebo. But the rate was 5% in vaxxed group vs 3% in placebo group.
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Somehow this has been a point of contention...both those figures are correct.
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Oh my god. Carol Hayes from the American College of Nurse Midwives tried to chime in to help out with the misunderstanding. She is muted before finishing her thought.
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We are less than one hour out from the scheduled time that the committee will vote on new Covid-19 vaccine recommendations. The voting language has not been made public.
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Consider this the 10,000-foot question that has guided the new ACIP as a whole: “Do we have a culture of safety?” That's the question Retsef Levi says has guided the Covid-19 working group's research. Many top public officials would say yes, emphatically. Levi would disagree.
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Retsef Levi says he thinks the Covid-19 vaccine should be prescribed.
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Levi, who is not a doctor and does not have an advanced degree in public health or pharmacy, speaks rather confidently that he thinks it should be pretty straight forward for at-risk Americans to just get a prescription for a Covid-19 vaccine rather than get one at a pharmacy.
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Hank Bernstein, a former ACIP member and current member of the vaccine advisory panel at the FDA with more than three decades of experience as a pediatrician, is now presenting what's been described as the "minority" opinion on the work group.
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Members of the public are expected to comment on four proposed votes that were made public seconds before they spoke.
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Do the three votes involving "the sense of the committee" have any legal binding element? I'm not sure those are anything more than statements.
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btw, "individual-based decision making" = shared clinical-decision making. So, the actual proposed vote here, is that all Americans consult a healthcare provider before getting a vaccine. Important: - insurers have to cover SCDM recs under ACA - pharmacists = providers under SCDM
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On Vote #4, to apply shared clinical-decision making to Covid-19 vaccines for all Americans: Yes: unanimous (this is really the only vote that has any practical impact)
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What a wild rollercoaster to essentially vote that all Americans can get a Covid-19 vaccine at their pharmacy for free.
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New ACIP member Hillary Blackburn is giving some succinct pharmacy 101 tips to some fellow ACIP members who want prescriptions to be required for Covid-19 vaccines.
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This is a long-winded conversation that appears to center on some members wanting a doctor to tell you that the mRNA vaccine is a gene therapy...I don't know how much a prescription really has anything to do with this.
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Vote on this: Yes: 6 No: 6 Chair breaks the tie. Kulldorff voted no. It doesn't pass.
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